Design for Approval - ComplianceFollow article
Congratulations! You have just made the first prototype of a Gizmo which is going to change the world... or is it?
These days it is relatively easy to design a product to perform a specific function, much of the work is done using computer simulations and more often than not the first prototype actually works, albeit with a few bugs to fix. But is this the whole story? Unless you are designing a product for a limited niche market, the objective is to design a world product. Markets are well regulated and measures are in place to keep ”failing” products out of the market, so what must you do to ensure that your world beating design will succeed?
This is the first in a series of articles aimed at the design engineer to assist you to design-in the key requirements which will ensure commercial success.
Regulations, regulations, regulations!
This is last thing a design engineer wants be get involved with, but legal requirements underpin the technical requirements in all the major markets. Probably the most recognisable and the most mis-interpreted are the CE marking requirements in the European Union.
Regulations are sometimes used to restrict access to markets, so called non-tariff barriers, but this is now becoming less of an issue. If I restrict your access to my market you may well do the same to me! The reality is that regulations are introduced to protect markets against “bad” products and to promote free trade in economic areas such as the EU and North America. There is a hierarchy with respect to legal requirements and technical standards: Laws, Statutes, and Directives are legal entities and rarely incorporate technical requirements, whereas the Standards, Regulations, Codes and Codes of Practice contain technical requirements which are usually mandatory compliance requirements. Many regulations have come about as technologies have evolved and new problems become apparent. Hence the explosion in regulations over the last 25 years!
Why do we need these regulations? The principle areas of regulation concern safety, efficient use of the (radio) spectrum, non-interference, energy efficiency and sustainability. All of these will be explored in more detail in subsequent articles.
A typical electrically powered product intended for use in Europe must comply with the Low Voltage, EMC, R&TTE, Battery, RoHS, and WEEE Directives and that is before some specialist requirements such as the Medical Device, Machinery, and ATEX Directives come into play! Note: there are no product specific Directives, even the technical standards are as generic as possible. Fifteen years ago it was still necessary to test to product specific standards, but the growth in innovative products and the timescales (often years) to develop new standards precludes this route to compliance. The stated objective of the European Union is to open up markets to innovation and not to stifle them with regulations. Maybe they didn’t get it 100% right, but there is no barrier to launching a new product on the market even if it is the first of its type ever made!
Europe has led the way with self-certification. CE marking of most products, deemed to be lower risk, is by demonstration of compliance which can be by assessment testing, calculation and design verification. The manufacturer compiles a Technical Compliance Folder (TCF) which contains the test data and comprehensive documentation on the design and operation of the product, user instructions and a Declaration of Conformity. The main exceptions e.g. medical devices, some machinery, ATEX (explosive atmosphere), gas appliances, etc. will require third party testing, certification by a Notified Body and routine manufacturing inspections to ensure ongoing compliance.
First the bad news; Compliance with European regulations does not guarantee that the product will comply with regulations in other markets. However, there are Mutual Recognition Agreements (MRAs) with many countries and economic areas which will allow EU test reports to be used for national approvals in a large number of countries. The notable exclusion is one of our biggest export markets, North America.
The US and Canadian compliance routes are largely certification led, e.g. assessment, certification and in some cases ongoing compliance by inspection of manufacturing facilities. The technical standards are only harmonised with the rest of the world in a limited number of cases, e.g. IT, Instrumentation and test equipment, medical devices. Otherwise a national standard issued by ANSI or UL will be used. These standards are not compatible with other national compliance regimes, but some countries will accept UL and FCC (EMC) test reports.
Looking further afield to Asia, certifications for countries such as China, Taiwan, and South Korea are not easy to handle directly. The assessment testing is performed in-country, local language documentation is required and in the case of some products requires routine manufacturing surveillance as well.
Like it or not, the route to market for most products will involve compliance with legal and technical requirements. Subsequent articles will explore the key aspects of product compliance process. Watch this space!
If you have any questions or would like to find out how this applies to your product, please contact:
Product Approvals Ltd - www.productapprovals.co.uk
Look out for the next article in the series:
Design for Approval - Compliance
Design for Approval - Safety
Design for Approval - EMC Can't Hurt You Can It?